MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565050
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex colonic stent was to be implanted in the sigma-colon to treat a stenosis during a colonoscopy procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, resistance was felt during attempted stent deployment and the handle of the stent delivery system broke.The stent was fully covered by the outer sheath when removed from the patient.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the wallflex enteral colonic stent and delivery system were returned for analysis.The stent was received fully covered and undeployed.Visual examination of the returned device found the outer clear sheath was kinked, the outer blue sheath was detached from the hub and the stainless steel handle was returned kinked and broken.A dimensional inspection of the delivery system was performed and found the length of the blue sheath was out of specification.Functional inspection could not be performed due to the broken handle.No other issues were noted to the stent and delivery system.The reported event of handle break and stent failure to deploy were confirmed.The damages noted of the returned device were most likely due to procedural factors encountered during the procedure.It may be that handling of the device, the techniques used by the user, tortuous anatomy and normal procedural difficulties, limited the performance of the device and contributed to the reported and observed failures.It is possible that factors and/or conditions related to patient anatomy during the use of the device could have affected its performance and its intended purpose.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to patient condition.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation on february 18, 2022 that a wallflex colonic stent was to be implanted in the sigma-colon to treat a stenosis during a colonoscopy procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, resistance was felt during attempted stent deployment and the handle of the stent delivery system broke.The stent was fully covered by the outer sheath when removed from the patient.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13776506
• Report Number: 3005099803-2022-01222
• Device Sequence Number: 3824400
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2023
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0027435204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown